Tracheostomy or endotracheal tube adapter for speech

ABSTRACT

A speaking valve adapter is disclosed for assisting with speech or language expression during the respiratory recovery of a human. The speaking valve adapter including a speaking valve port, the port being orthogonal to a first interface port, the first interface port adapted to support tracheostomy or endotracheal tubing, a second interface port adapted to support at least one of a suction tubing and a bronchoscopy tubing, and a third interface port adapted to support a connection to a ventilator. The speaking valve adapter may be used by the patient for introduction of at least one of sounds and words while connected to the ventilator. A corresponding respiratory management system which implements the speaking valve adapter and configurable ventilator settings adapted for assisting with more effective speech or language expression during patient recovery or use, is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.15/119,225, filed on Aug. 16, 2016, now U.S. Pat. No. 10,532,171, whichis the U.S. National Phase of International Application No.PCT/US2015/048574, filed on Sep. 4, 2015, which claims priority to andthe benefit of U.S. Provisional Application No. 62/057,326 filed on Sep.30, 2014. Each of the foregoing applications is incorporated byreference herein in its entirety, for all purposes.

FIELD OF THE DISCLOSURE

The present disclosure relates to a speaking valve adapter implementedwith a breathing apparatus or ventilator and related system, and moreparticularly, to a ventilator tracheostomy or endotracheal tube adapterfor speech that may be implemented with current ventilator technologies.The disclosure permits the implementation of the improved featuresavailable in current ventilator technologies while permitting thepatient to rehabilitate their lungs and/or respiratory airways duringtheir recovery more effectively.

BACKGROUND

Speaking valves are generally utilized for patients that require atracheostomy for breathing. In certain cases, patients are recoveringfrom a debilitating lung injury or from a serious respiratory illnesssuch as pneumonia that requires the patient's dependency on a ventilatorfor breathing during the recovery period or for an indefinite period oftime. Other patients, such as quadriplegics may require a ventilator forbreathing on a permanent basis. Tracheostomies are generally known toresult in fewer complications for patients and generally recommendedearly on during treatment and recovery.

Tracheostomies are utilized via an opening surgically created throughthe neck into the trachea permitting access for breathing and iscommonly done in an operating room under general anesthesia. A tube isusually placed through this opening to provide an airway and to removesecretions from the lungs. Thus, breathing or ventilation isaccomplished through the tracheostomy tube rather than through the noseand mouth. The incision into the trachea (windpipe) forms a temporary orpermanent opening which connects via the tracheostomy tube to aventilator so the patient can safely recover while maintainingrespiration.

However, one of the problems faced by patients that require atracheostomy tube is that speaking often becomes a challenge. Exhaledair generally does not pass through their larynx but, rather exits fromthe tracheostomy tube. A speaking valve is often attached to thetracheostomy tube to direct air flow through the vocal cords when apatient exhales. The speaking valve thus closes during exhalation,causing air to travel up the trachea around the tracheostomy tube,through the larynx and out of the patient's nose or mouth. Thisre-directed air path permits speech in the patient.

While speaking valves have been implemented to assist the patient withspeaking, the use of such valves includes various drawbacks. Some of theconcerns with one-way speaking valves have included occlusion problems,safety, high resistance levels, size, adaptability, restriction duringinspiration, and leakage of exhaled air backing out through the valve.

Many speaking valves are designed in a biased-closed position that openonly during inspiration and start to close before the end of theinspiratory cycle/beginning of the expiratory cycle. The air is thendirected around the tracheostomy tube, through the vocal cords and outthrough the oral and nasal cavities of the patient. Thus, a column ofair is trapped within the speaking valve and the tracheostomy tube actsas a buffer to resist movement of secretions that move up thetracheostomy tube and into the speaking valve. Such speaking valves,while permitting patients to speak normally, have serious drawbacks inconnection with their use. First, the tracheostomy tube must operatewith the cuff of the tracheostomy tube always completely deflated whichotherwise creates a dangerous obstruction to exhaled air flow. Warninglabels are often indicated in proximity to the patient's bedside and/orchart in order to monitor the balloon of the patient's cuffedtracheostomy tube. Another drawback is the case in which controlling theventilation and preventing gross aspiration is required, in order toprevent the tracheostomy tube cuff from being deflated. The speakingvalves cannot be used in such cases since it would cause an obstructionto exhaled air flow and the patient would not be able to be safelyventilated. An additional drawback of speaking valves is for unconsciousor comatose patients who are unable to speak in such states, and wouldrequire constant monitoring when such speaking valves are implementedwith ventilation systems. Speaking valves are generally not suitableduring extensive sleep patterns of patients, especially in unconsciousor comatose patients. An additional complication is that any inadvertentre-inflation of the cuff can also occur with a foam-filled cuffedtracheostomy. The pilot line of a foam-filled cuffed tracheostomy tubemust be plugged in to prevent the cuff from re-inflating. Therefore, theuse of speaking valves can be hazardous when implemented with afoam-filled cuffed tracheostomy tube.

As described, there exists a need in the art for a ventilatortracheostomy adapter that not only permits optimal use of more advancedventilator technologies implementing existing tracheostomies whichadditionally permit the continuous use of the ventilator with markedimprovement in the speech of patients or simply, the ability to evenspeak, while reducing numerous potential complications and drawbacks ofexisting speaking valves. An advantage of such improved adapter featuresis the possibility for refined calibration of continuous ventilatorsupport in both the inspiratory and expiratory phases of respirationwhich leads to improved weaning of the patient from dependency on theventilator for breathing as is described in greater detail below.

SUMMARY

Embodiments of the disclosure will become apparent from the followingdetailed description considered in conjunction with the accompanyingdrawings. It is to be understood, however, that the drawings aredesigned as an illustration only and not as a definition of the limitsof this disclosure.

In accordance with an embodiment or aspect, disclosed is a speakingvalve adapter for assisting with speech or language expression duringrespiratory recovery of a human with respiratory failure. The speakingvalve adapter includes a speaking valve port. The port is orthogonal toa first interface port, and the first interface port is adapted tosupport tracheostomy or endotracheal tubing. A second interface port isadapted to support at least one of a suction tubing and a bronchoscopytubing. A third interface port is adapted to support a connection to aventilator.

In accordance with another embodiment or aspect, the speaking valveadapter is further used by the patient for introduction of at least oneof sounds and words while connected to the ventilator. The firstinterface port further includes a swivel adapter surrounding the openingchannel to the first interface port. The swivel adapter may be furtherconfigured to have increased flexibility between the tracheostomy andthe patient. The speaking valve adapter yet may further include thethird interface port being further configured to include a swiveladapter surrounding the channel to the third interface port. The swiveladapter may yet be further configured to consist of material havingincreased flexibility, thereby increasing the user's range of movementwhile connected to the ventilator.

In accordance with yet another embodiment or aspect, the speaking valveadapter further includes the second interface port comprising a plug forconnection to an opening of the third interface port, thereby closingthe opening to the third interface port. The third interface port mayfurther comprise a plug for connection to an opening of the thirdinterface port, thereby closing the opening to the third interface port.The speaking valve adapter may yet further comprise a plug forconnection to an opening of the speaking valve adapter, thereby closingthe opening to the speaking valve adapter. The tracheostomy may yetfurther include a cuff disposed along tubing of the tracheostomy. Thetracheostomy may yet further include a cuff used during inflation ordeflation of the cuff without risk of injury associated with connectionto the ventilator.

In accordance with yet another embodiment or aspect, the speaking valveadapter is further configured to include a positive end expiratorypressure level being set on the ventilator while diverting air throughthe vocal cords during speech, thereby minimizing respiratorycomplications during speech. The speaking valve adapter may furtherinclude inspiration including simultaneous inspiration from outsideatmospheric air at sea level pressure and pressure support from theventilator. The speaking valve adapter may yet further includeoptimizing at least one ventilator parameter to reduce overall durationof ventilation and organ failure associated with connection to theventilator.

In accordance with yet another embodiment or aspect, a respiratorymanagement system is disclosed that implements a speaking valve adapterfor assisting with speech or language expression during respiratoryrecovery of a human patient. The system includes a ventilator configuredto permit a human's lungs to deflate and rapidly inflate continuously tomaintain the lungs nearly inflated. The adapter is further configured toinclude a speaking valve port, the port being orthogonal to a firstinterface port, the first interface port adapted to support tracheostomyor endotracheal tubing, a second interface port adapted to support atleast one of a suction tubing and a bronchoscopy tubing, and a thirdinterface port adapted to support a connection to a ventilator.

In accordance with yet another embodiment or aspect, a speaking valveadapter is disclosed for assisting with speech or language expressionand respiratory therapy during respiratory recovery of a human withrespiratory failure. The speaking valve adapter further includes aspeaking valve port, the port being orthogonal to a first interface portand a third interface port. The speaking valve port adapted to becouplable to at least one of a ventilator device, an expap/hyperinflation positive pressure manifolds system, a resuscitationdevice, a negative inspiratory force manometer, a respirometerspirometer device, a nebulizer device, a positive end expiratorypressure regulator, a speaking valve, an incentive spirometer, a coughassist device, and an end tidal capnography monitoring device. Thespeaking valve adapter further includes a first interface port adaptedto be couplable to a tracheostomy or an endotracheal tubing. Thespeaking valve adapter yet further includes a second interface portadapted to be couplable to at least one of: a ventilator device, an expap/hyperinflation positive pressure manifolds system, a resuscitationdevice, a negative inspiratory force manometer, a respirometerspirometer device, a nebulizer device, a positive end expiratorypressure regulator, an incentive spirometer, a cough assist device, andan end tidal capnography monitoring device. The speaking valve adapteryet further includes the third interface port being adapted to becouplable to at least one of: a resuscitation device, a negativeinspiratory force manometer, and a nebulizer device.

In accordance with a further embodiment or aspect, the speaking valveadapter is used by the patient for introduction of at least one ofsounds and words while connected to the ventilator. The first interfaceport further includes a swivel adapter surrounding the opening channelto the first interface port. The swivel adapter is further configured tohave increased flexibility between the tracheostomy and the patient. Thethird interface port is further configured to include a swivel adaptersurrounding the channel to the third interface port. The swivel adapteris yet further configured to consist of material having increasedflexibility, thereby increasing range of movement of the patient whileconnected to the ventilator. The swivel adapter is yet furtherconfigured to consist of material having increased flexibility, therebyincreasing the range of movement of the patient, while connected to theventilator. The second interface port yet further comprises a plug forconnection to an opening of the third interface port, thereby closingthe opening to the third interface port. The third interface portfurther comprises a plug for connection to an opening of the thirdinterface port, thereby closing the opening to the third interface port.The speaking valve adapter further comprises a plug for connection to anopening of the speaking valve adapter, thereby closing the opening tothe speaking valve adapter. The tracheostomy further includes a cuffdisposed along tubing of the tracheostomy. The tracheostomy yet furtherincludes a cuff being used during inflation or deflation of the cuffwithout risk of injury associated with connection to the ventilator. Thespeaking valve adapter yet further includes a positive end expiratorypressure level being set on the ventilator while diverting air throughthe vocal cords during speech, thereby minimizing respiratorycomplications during speech. The speaking valve adapter further includesinspiration that includes simultaneous inspiration from outsideatmospheric air at sea level pressure and pressure support from theventilator. The speaking valve adapter yet further includes at least oneventilator parameter configured to reduce overall duration ofventilation and organ failure associated with connection to theventilator. The speaking valve adapter yet further includes configuringone ventilator parameter by optimizing ventilator management of thehuman, thereby reducing the overall duration of ventilation and organfailure associated with connection to the ventilator.

In accordance with yet another embodiment or aspect, a respiratorymanagement system is disclosed for assisting with speech or languageexpression during respiratory recovery of a human patient. The systemincludes a speaking valve adaptor and a ventilator having settingsconfigured to permit a human's lungs to deflate and rapidly inflatecontinuously to maintain the lungs nearly inflated. The speaking valveadapter further includes a speaking valve port, the port beingorthogonal to a first interface port and a third interface port, thespeaking valve port adapted to be couplable to at least one of aventilator device, an ex pap/hyperinflation positive pressure manifoldssystem, a resuscitation device, a negative inspiratory force manometer,a respirometer spirometer device, a nebulizer device, a positive endexpiratory pressure regulator, a speaking valve, an incentivespirometer, a cough assist device, and an end tidal capnographymonitoring device. The speaking valve adapter further includes a firstinterface port adapted to be couplable to a tracheostomy or anendotracheal tubing. The speaking valve adapter yet further includes asecond interface port adapted to be couplable to at least one of: aventilator device, an ex pap/hyperinflation positive pressure manifoldssystem, a resuscitation device, a negative inspiratory force manometer,a respirometer spirometer device, a nebulizer device, a positive endexpiratory pressure regulator, an incentive spirometer, a cough assistdevice, and an end tidal capnography monitoring device. The speakingvalve adapter yet further includes the third interface port beingadapted to be couplable to at least one of: a resuscitation device, anegative inspiratory force manometer, and a nebulizer device.

In accordance with a further embodiment or aspect, the respiratorymanagement system further includes the speaking valve adapter being usedby the patient for introduction of at least one of sounds and wordswhile connected to the ventilator. The first interface port furtherincludes a swivel adapter surrounding the opening channel to the firstinterface port.

In accordance with yet a further embodiment or aspect, the respiratorymanagement system includes a ventilator with ventilator settings whichare configurable to assist the patient with speech expression duringrespiratory recovery of the patient. The ventilator settings yet furtherinclude at least one of N A/C and V-TRIG parameters.

Embodiments will become apparent from the following detaileddescription, which is to be read in connection with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings constitute a part of this disclosure and include examples,which may be implemented in various forms. It is to be understood thatin some instances, various aspects of the disclosure may be shownexaggerated or enlarged to facilitate understanding. The teaching of thedisclosure can be readily understood by considering the followingdetailed description in conjunction with the accompanying drawings.

FIG. 1A is an illustration of a first preferred embodiment of thetracheostomy adapter for attachment to a ventilator.

FIG. 1B is an illustration of an additional embodiment of thetracheostomy adapter for attachment to a ventilator.

FIG. 2 is an illustration of a second embodiment of the tracheostomyadapter for attachment to a ventilator.

FIG. 3 is an illustration of a third embodiment of the tracheostomyadapter for attachment to a ventilator.

FIG. 4 is an illustration of a cuffed tracheostomy tube inserted in thetrachea of a patient.

FIG. 5 is an illustration of an un-cuffed tracheostomy tube inserted inthe trachea of a patient.

FIG. 6 is an illustration of an exemplary known tracheostomy valve withattachment port to a ventilator.

FIG. 7 is an illustration of an endotracheal tube as inserted in thetrachea of a patient.

FIG. 8 is an illustration of the main respiratory airways of a human.

FIG. 9 is an illustration of an example Edi catheter.

FIG. 10 is an illustration of an example ECG and Edi signal readingincluding PEEP, Oxygen, and additional levels.

FIG. 11 is an illustration of an example prototype ventilatorimplemented with the tracheostomy adapter of the present invention.

It is to be appreciated that elements in the figures are illustrated forsimplicity and clarity. Common but well-understood elements, which maybe useful or necessary in a commercially feasible embodiment, are notnecessarily shown in order to facilitate a less hindered view of theillustrated embodiments.

DETAILED DESCRIPTION

It is noted that known speaking valves are generally designed to bein-line with the ventilator attachment. The disclosed technologyovercomes the shortcomings resulting from this “in-line” design andintroduces additional advantages to the recovery of the lungs during theweaning process using traditional as well as more current ventilatortechnologies. Additionally, there are added advantages in implementingthe newer ventilator technologies in treatment centers, such advantagesare described in greater detail below. The present disclosure alsopermits simultaneous ventilation and suctioning via asuction/bronchoscopy port which is another advantage over known designs.Existing speaking valves cannot be utilized in line if the tracheostomycuff is inflated. Otherwise, patients face the risk of lungover-expansion and/or hyperinflation if attached in line to theventilator while using such valves while the cuff is inflated. Air flowsmainly to the outside when the cuff is deflated. However, when the cuffis inflated, all air egresses back into the endotracheal or tracheostomytube, not only making speech impossible, but, causing a medicallydangerous condition. Foam filled cuffed tracheostomy tubes also cannotbe implemented with in-line speaking valve devices without the risk oflung overexpansion if the cuff re-inflates. Known speaking valves cannotbe easily implemented with endotracheal tubes. Additionally, knownspeaking valves are not indicated for use with unconscious or comatosepatients.

A speaking valve adapter (1) in accordance with the disclosed invention,is shown in FIG. 1A as a preferred embodiment. The speaking valveadapter (1) may be attached to the external adapter (50) of a standardtracheostomy tube (44) as shown in FIG. 4 and FIG. 5, at elements (40)and (50), respectively, whether the tracheostomy tube (44) is cuffed(41) or an un-cuffed model, for example, as shown in FIG. 5. Thespeaking valve adapter (1) in some embodiments or aspects, is attachedto the external adapter of a standard endotracheal tube (70) as shown inFIG. 7.

The disclosed speaking valve adapter (1) in FIG. 1A permits attachmentto either a tracheostomy or an endotracheal tube (70) at opening (6) ofcylindrical tracheostomy port (9). A simple tracheostomy is generallyinserted below the vocal cords of the patient. The airflow generallybypasses the vocal cords and thus, no speech is possible while connectedto a tracheostomy if the balloon is inflated. When patients requireventilation for several weeks, a tracheostomy as shown in FIG. 4 and/orFIG. 5, provides better suited access to the trachea (42). Thetracheostomy is a surgically created passage into the trachea (42). Theyare generally well-tolerated. However, many tracheostomies include a“cuff” (41), which is associated with risks as described in greaterdetail below.

Prior to tracheostomy, endotracheal intubation is customary. It includesthe placement of a flexible plastic endotracheal tube (70) into thetrachea (42) to maintain an open airway serving as a conduit formechanical ventilation if indicated for the patient. Either method offacilitating connection to a ventilator may be indicated for a patientdepending on the patient's condition. As shown in FIG. 1A, thetracheostomy port (9) also includes a swivel adapter (8) that rotatesabout the cylindrical body of the tracheostomy port (9) at opening (8).The swivel adapter (8) connects likewise to either a tracheostomy tube(44) of FIG. 4 or an endotracheal tube (70) as shown in FIG. 7, forexample. It is noted, that if an endotracheal tube (70) is inserted inthe trachea (42) as shown in FIG. 7, the exhaled airflow of the patientgoes back through the endotracheal tube (70) into the ventilator andthus, bypassing the vocal cords. No airflow can egress through the vocalcords to permit speech, if the cuff is inflated with either anendotracheal tube or tracheostomy. As already described, bothendotracheal tube (70) and tracheostomy tube (44) are designed to have acuff (41) or inflatable balloon, which is inflated and occupies the fulldiameter of the patient's internal tracheal diameter (43), as shown inFIG. 4. The cuff (41) in FIG. 4 is able to inflate or deflate with thesame degree of air pressure under strictly controlled conditions, whichgenerally serves to prevent a pressure “sore” on the internal tissues ofthe tracheal wall (45), among other functions.

One of the advantages of the swivel feature of the adapter (1) of FIG.1A, is that the patient is able to move about comfortably while thetracheostomy tube is connected to the patient, which permits greaterfreedom of movement and flexibility for the tracheostomy tube itself asthe patient moves about. The swivel adapter (8) will pivot or rotateabout the opening (6) to the cylindrical body of the tracheostomy port(9) which increases flexibility in use for the patient as well asincreases the patient's level of comfort. The swivel adapter (8) willalso prevent any potential snagging or any other condition that wouldotherwise cause any physical obstruction of airflow via the tube due toconstriction of movement of the valve. The swivel adapter (8) expandsthe patient's range of movement while connected thereto. The swiveladapter (8) in certain embodiments or aspects, can be further configuredto be manufactured of a flexible material such as for example,polyurethane, medical grade, resulting in even greater flexibilityand/or ability to rotate while the patient is connected to theventilator and the tracheostomy. This feature will increase thepatient's level of comfort. The patient's ability to rest comfortablyand relax while connected to the ventilator, is also considered asignificant factor that improves the overall recovery process. Hence,the swivel adapter (8) at the tracheostomy port (9) contributes to thepatient's overall comfort, by increasing their freedom of movement.

The speaking valve adapter (1) also includes a cylindrical port (5) thatsupports the speaking valve (15). The speaking valve (15) may beremovable in some embodiments or aspects, and/or include a removable cap(10) in certain embodiments. The removable cap (10) also permitscovering the port by insertion of a plug (13) into the port (5) opening(11) in the instance, for example, when the patient does not want theassistance of the speaking valve (15). Thus, the removable cap (10)serves to cover the opening, reducing incidence of contamination by anyforeign substances.

The cylindrical ventilator port (17) supporting attachment to theventilator at opening (2), is enclosed by outer swivel adapter (7) onits outer surface, to permit greater freedom of movement for the patientwhile connected to the ventilator. There are also fewer occurrences ofany obstruction of airflow with the outer swivel adapter (7), as itincreases flexibility in use, and increases patient's level of comfort.In addition, the swivel adapter (7) decreases occurrences of anyphysical conditions in the attachment(s) to the ventilator that couldform an impediment or obstruction of the airflow, thus impeding properfunctioning of the ventilator. An incidental result of increasing thepatient's flexibility of use is simultaneously increasing the patient'slevel of comfort and generally, the patient's breathing level is alsogenerally enhanced.

The suction/bronchoscopy port (4) is shown having an opening (14) forsupporting attachment to a suction or bronchoscope. A bronchoscope is along, narrow, fiberoptic, lighted viewing tube inserted through the noseor mouth. The physician can view as shown for example in FIG. 8, in anon-intubated patient, the vocal cords, the trachea (80), bronchi (83)(large airways to the lungs), and bronchioles (81) (smaller branches ofthe bronchi) in order to evaluate, diagnose and/or treat certain areasincluding performance of biopsies for examination of tissue, ifmedically indicated. The physician or health care provider may alsoremove secretions or foreign bodies and provide specialized treatmentsusing such bronchoscopy procedures. In other embodiments or aspects, ina patient with a tracheostomy, the vocal cords are not seen during abronchoscopic evaluation.

The suction/bronchoscopy port (4) of FIG. 1A, includes a removable cap(12) with plug (16) attached to the cap. The removable cap (12) withplug (16) is used to close the opening (14) to the suction/bronchoscopyport (4) when not in use or connected to the suction or bronchoscope. Anadditional plug (3) found above the distal end of the swivel adapter (7)of the ventilator port attachment at opening (2), may be used to closethe opening (14) of the suction/bronchoscopy port (4) in the event forexample, that the removable cap (12) is removed from the outercylindrical surface of the suction/bronchoscopy port (4).

As described above, the disclosed speaking valve adapter (1) of FIG. 1Ais designed to include a speaking valve (15) that is orthogonal with anddirectly connects to the tracheostomy port (9), rather than the priorart design of FIG. 6, in which the prior speaking valve (60) is arrangeddirectly in-line and connects to the ventilator port (61) as shown inFIG. 6. The design of the disclosed embodiment is associated withimproved results for both speaking ability and speech therapy duringrespiratory therapy. The disclosed embodiment is also associated with animproved weaning process for patients connected to newer ventilatortechnologies. These ventilators are also more finely calibrated and aremore tailored to a patient's unique needs. For example, certain of theventilator technologies implement sensors that are neural-based. Thesesensors and ventilators work with a specialized nasal/oral gastric tube,while also sensing the electrical pulses sent from the brain to thediaphragm (82) as shown in FIG. 8. These sensors allow the ventilator todeliver pressure proportionally to the amount of diaphragmatic activityit measures. These newer ventilator technologies may use diaphragmaticelectromyography to trigger ventilation in a more natural manner. Thistechnology assists Respiratory Therapy personnel and physicians inadjusting ventilators to facilitate and mimic more natural breathingpatterns for the patient in accordance with measured bodily responsesand demands. The newer ventilators thereby generate a more normalbreathing pattern for the patient who could not otherwise breathenormally and in sync with the ventilator. The disclosed speaking valveadapter (1) is designed to coordinate with these finely-tuned ventilatortechnologies that are more tailored towards the patient's level offunctioning with greater accuracy while permitting adjustments inaccordance with the patient's measured bodily functions. Whileconventional mechanical ventilators sense a patient's efforts by eithera drop in airway pressure or a reversal in air flow, newer technologiesevaluate electrical activity of the diaphragm and/or brain signals tocouple the diaphragm and the ventilator's functioning near or actuallyinstantaneously. This, in effect, synchronizes the patient's currentbreathing patterns with that of the ventilators.

The patient's expiratory cycle which is in tune with the patient'sdiaphragm cycle, may also be set by a practitioner. These featuresaffect the ability to develop and initiate speech in the patient. Morespecifically, the expiratory back pressure created in ventilator tubingand during the ventilator's expiratory phase forming the patient'sexpiratory cycle may be set by the practitioner. Therefore, certainvalues such as PEEP or EPAP can be adjusted (as described in greaterdetail below). PEEP (positive end-expiratory pressure) is the pressurein the lungs above atmospheric pressure (the pressure outside of thebody) that exists at the end of expiration. The two types of PEEP areextrinsic PEEP (PEEP applied by a ventilator) and intrinsic PEEP (PEEPcaused by a non-complete exhalation). Pressure that is applied orincreased during an inspiration is the pressure support in which thepatient initiates every breath and the ventilator delivers support withthe preset pressure value. EPAP (expiratory positive airway pressure)refers to the positive airway pressure being provided to the patient bythe ventilator while the patient breathes out.

The above-described airflow paths do not create speech in and of itself,but by virtue of back pressure, can promote diversion of air flowthrough the vocal cords. Ventilator technologies also overcome theproblems associated with older ventilators such as collapse of tiny airsacs at the end of the bronchiole as the cough reflex is absent and nonatural, periodic or continuous positive and expiratory pressure beingavailable naturally. In addition, current ventilator technologies alsoimplement the monitoring of the diaphragm's activity, similar tomonitoring an additional vital sign. This permits adjustments to theventilator to facilitate breathing for each patient according to eachperson's unique bodily demands and functions, thereby mimicking orsimulating a more normal breathing pattern. The newer ventilatortechnologies also are more geared towards improving the patients'recovery cycles and weaning the patients off the ventilators as soon aspossible. The longer a patient is connected to a ventilator, the morerisks for complications are present such as ventilator associatedpneumonia and/or other injury related to the lungs and airways of ahuman.

Additionally, the newer ventilator technologies are associated withdecreased duration of ventilator periods with developed weaningprotocols having improved monitoring features while avoiding additionalunnecessary sedation. Conventional ventilator technologies often rely onexternal indicators and since intubated patients are often unable tocommunicate their symptoms, etc. either due to sedation and/or lack ofspeaking abilities, it was often difficult for health care providers tointerpret physiological changes indicated by monitors. In addition,these external indicators were oftentimes not accurate enough norindicators of the patient's true state of condition and recovery. Forexample, symptoms such as rapid breathing, rapid heart rate, oragitation could be treated with sedating medications which couldactually increase any respiratory failure. The streamlined and/or morecurrent ventilators provide additional information to assist providerswith determining whether further ventilator adjustments are required tomodify ventilator support or whether the symptoms are arising from adifferent cause. Sensors allow these ventilators to deliver pressureproportional to the amount of diaphragmatic activity measured therebyallowing providers to adjust the ventilator according to theindividual's bodily demands.

The disclosed technology utilizes these improved features associatedwith newer ventilator technologies while assisting health care providerswith rehabilitating or improving speech during the weaning process fromventilators. While the newer ventilators are more optimal in weaning thepatients from the ventilator, the use of the disclosed adapter iscomplimentary to these newer ventilators and assist with weaning thepatients from dependence on the ventilators generally sooner than withconventional ventilators.

Known speaking valves are not indicated for improvement of the weaningprocess while permitting speech recovery efforts because of the alreadydescribed drawbacks in such known devices. As described, an example of aknown speaking valve device is shown in FIG. 6. This valve (60) designedto be “in-line” with the ventilator port (61), attaches to theventilator at such port. The attachments to the patient tracheostomy(62) and the suction/bronchoscopy port (63) are in-line to the speakingvalve (60) and thus, the ventilator attachment port (61). This knowndevice is associated with many of the already described disadvantages.

The process of weaning involves the gradual reduction of the amount ofwork that is performed by the ventilator as the patient's respiratorysystem gradually recovers or heals from their injury. Part of therecovery process for a patient is permitting the patient's own musclesto gradually function independently and be restored to the same level offunctioning as prior to the patient's injury or respiratory illness,etc. The newer ventilators also have a wide variety of modes forventilation to suit the unique nature of the patient's respiratoryinjury while permitting weaning sooner. Ventilators include complexpressure modalities which offer diverse ways to control the air pressureand ventilator support whether the patient is assisted with inhaling orexhaling. Some of the various modalities of ventilators include IMV(intermittent mandatory ventilation), SIMV (synchronized intermittentmandatory ventilation), pressure control, airway pressure release,assist control, volume control, volume assist, bi-level, BIPAP (bi-levelpositive airway pressure), CPAP (continuous positive airway pressure),etc.

Some of the recent additions are pressure control ventilation, pressuresupport ventilation, and synchronous intermittent mandatory ventilation(SIMV). SIMV is designed to provide assured rates and tidal volumes notcompeting with the patient's own spontaneous efforts. SIMV cansynchronize the patient's breathing with ventilator operations, thusreducing the patient's tendency to fight the ventilator and the need forsedation or other narcotics for the patient to better toleratemechanical ventilation. Synchronizing the patient's efforts with theventilator provides significant clinical advantages than previousconventional CMV (continuous mandatory ventilation). Associated risksassociated with typical mechanical ventilators include for example,barotrauma, ventilator-associated lung injury, and/or atrophy ofdiaphragm related muscles.

FIG. 8 is an illustration of the human main airways including trachea(80), bronchus (83), bronchioles (81) and diaphragm (82) located belowthe right (85) and left (84) lungs. It is the diaphragm (82) and relatedmuscles which are important to develop strength to aid in the weaningprocess from the ventilator.

Another contemplated embodiment of the disclosed speaking valve adapter(28) is illustrated in FIG. 1B. Similar to the adapter (1) shown in FIG.1A, the adapter (28) shown in FIG. 1B permits attachment to either atracheostomy or an endotracheal tube (70) at opening (6) of cylindricalport (9). As described in FIG. 1A, a simple tracheostomy is generallyinserted below the vocal cords of the patient. The airflow generallybypasses the vocal cords and thus, no speech is possible while connectedto a tracheostomy if the balloon is inflated. When patients requireventilation for several weeks, a tracheostomy as shown in FIG. 4 andFIG. 5 provides better suited access to the trachea (42). Thetracheostomy is a surgically created passage into the trachea (42). Theyare generally well-tolerated. However, many tracheostomies include a“cuff” (41) which is associated with risks, as described in greaterdetail below.

Prior to tracheostomy, endotracheal intubation is customary.Endotracheal intubation includes the placement of a flexible plasticendotracheal tube (70) into the trachea (42) to maintain an open airwaythereby serving as a conduit for mechanical ventilation, if indeedindicated for the patient. Either method of facilitating connection to aventilator may be indicated for a patient depending on the patient'scondition. As shown in FIG. 1B, the port (9) also includes a swiveladapter (8) that rotates about the cylindrical body of the tracheostomyport (9) at opening (6). The swivel adapter (8) connects likewise toeither a tracheostomy tube (44) as shown for example in FIG. 4 or anendotracheal tube (70) as shown for example, in FIG. 7. It is noted thatif an endotracheal tube (70) is inserted in the trachea (42) as shown inFIG. 7, the exhaled airflow of the patient goes back through the tube(70) into the ventilator and thus, bypassing the vocal cords. No airflowcan egress through the vocal cords to permit speech if the cuff isinflated with either an endotracheal tube or tracheostomy. As described,both endotracheal tube (70) and tracheostomy tube (44) are designed tohave a cuff (41) or inflatable balloon which is inflated and occupiesthe full diameter of the patient's internal tracheal diameter (43) asshown in FIG. 4. The cuff (41) in FIG. 4 is able to inflate or deflatewith the same degree of air pressure under strictly controlledconditions which generally serves to prevent a pressure “sore” on theinternal tissues of the tracheal wall (45) among other functions.

One of the advantages of the swivel feature of the adapter (1) of FIG.1B, is that the patient is able to move about comfortably while thetracheostomy tube is connected to the patient, which permits greaterfreedom of movement and flexibility for the tracheostomy tube itself asthe patient moves about. The swivel adapter (8) will pivot or rotateabout the opening (6) to the cylindrical body of the tracheostomy port(9) which increases flexibility in use for the patient as well asincreases the patient's level of comfort. The swivel adapter (8) willalso prevent any potential snagging or any other condition that wouldotherwise cause any physical obstruction of airflow via the tube due toconstriction of movement of the valve. The swivel adapter (8) expandsthe patient's range of movement while connected thereto. The swiveladapter in certain embodiments can be further configured to bemanufactured of a flexible material such as for example, polyurethane,medical grade, resulting in even greater flexibility and/or ability torotate while the patient is connected to the ventilator and thetracheostomy. This feature will increase the patient's level of comfort.The patient's ability to rest comfortably and relax while connected tothe ventilator is also considered a significant factor that improves theoverall recovery process. Hence, the swivel adapter (8) at thetracheostomy port (9) contributes to the patient's overall comfort, byincreasing their freedom of movement.

The speaking valve adapter (38) also includes a cylindrical-shaped portB (38) connected with and supporting the speaking valve (15). Thespeaking valve (15) may be removable in some embodiments and/or includea removable cap (10) in certain embodiments. The cap (10) also permitscovering the port by insertion of a plug (13) into the multi-attachmentPort B (38) opening (11) in the instance for example, when the patientdoes not want the assistance of the speaking valve (15). Thus, the cap(10) serves to cover the circular opening thereby reducing incidence ofcontamination by any foreign substances or dust.

The cylindrical-shaped multi-attachment Port A (39) supports attachmentto for example, the ventilator at opening (2). There are additionalmedical tubing and/or devices that are attachable to Port A (39). Aventilator device or ventilator circuit attachment is attachable tomulti-attachment Port A (39) or alternatively, to multi-attachment PortB (38). In oxygenation newer low and high flow continuous 0-2 deliverysystems can be used via the side, multi-attachment Port A (39) whilestill being able to utilize suction ability as well as a speech enablingvalve. Additional oxygenation resources such as CPAP systems can beapplied via the ventilator Port A. CPAP systems can simultaneouslydeliver higher oxygen concentrations. This would be identical in conceptof using multi-attachment Port A (39) for ventilatory support, withmulti-attachment Port B (38) preserving utilization of a speaking valvei.e. Passy-Muir, and multi-attachment Port C (37) for suctioning.

In an embodiment or aspect of the adapter device (28), a hi-flow aerosoltubing may be attached with a 15 mm to 22 mm adapter viamulti-attachment Port B (38) or multi-attachment Port C (37). This willallow both ventilation via multi-attachment Port A (39) and delivery ofmedicine(s) via multi-attachment Port C (37) or multi-attachment Port B(38), if a speaking valve is not attached thereto. Many respiratorytherapy supplies use a universal diameter of 15 mm, although certaintubing has a diameter of 22 mm Thus many products will require aconversion adaptor from a 15 mm adaptor to 22 mm or vice versa.

An EZ PAP/hyperinflation positive pressure manifolds system in certainembodiments, attaches to multi-attachment Port A (39) or alternatively,to multi-attachment Port B (38). In yet other contemplated embodiments,a bag valve manual resuscitation device is attachable tomulti-attachment Port A (39); or alternatively, to multi-attachment PortB (38); or alternatively to multi-attachment Port C (37). In yet othercontemplated embodiments, a negative inspiratory force manometer isattachable to multi-attachment Port A (39); or alternatively, tomulti-attachment Port B (38); or alternatively to multi-attachment PortC (37). In yet other contemplated embodiments, Wright's RespirometerSpirometer is attachable to multi-attachment Port A (39); oralternatively, to multi-attachment Port B (38). In yet othercontemplated embodiments, negative inspiratory force manometer isattachable to multi-attachment Port A (39); or alternatively, tomulti-attachment Port B (38); or alternatively, to multi-attachment PortC (37). In yet other contemplated embodiments, a BIPAP/CPAP circuit isattachable to multi-attachment Port A (39). In yet other contemplatedembodiments, a medication nebulization device is attachable tomulti-attachment Port A (39); or alternatively, to multi-attachment PortB (38); or alternatively to multi-attachment Port C (37). In yet othercontemplated embodiments, a positive end expiratory pressure regulatoris attachable to multi-attachment Port A (39); or alternatively, tomulti-attachment Port B (38). In yet other contemplated embodiments, aspeaking valve/one-way flow valve is attachable to multi-attachment PortB (38). In yet other contemplated embodiments, an inventive spirometeris attachable to multi-attachment Port A (39); or alternatively, tomulti-attachment Port B (38). In yet other contemplated embodiments, acough assist device is attachable to multi-attachment Port A (39); oralternatively, to multi-attachment Port B (38). In yet othercontemplated embodiments, an end tidal capnography monitoring device isattachable to multi-attachment Port A (39); or alternatively, tomulti-attachment Port B (38).

Multi-attachment Port A (39) is enclosed in certain embodiments by aswivel adapter (7) on its outer surface to permit greater freedom ofmovement for the patient while connected to the ventilator. There arealso fewer occurrences of any obstruction of airflow with the swiveladapter (7) as it increases flexibility in use, and increases patient'slevel of comfort. In addition, the swivel adapter (7) decreasesoccurrences of any physical conditions in the attachment(s) to forexample, the ventilator that could form an impediment or obstruction ofthe airflow, thus impeding proper functioning of the ventilator. Anincidental result of increasing the patient's flexibility of use issimultaneously increasing the patient's level of comfort and generally,the patient's breathing level is also generally enhanced.

The third multi-attachment Port C (37) is shown having an opening (14)for supporting attachment to a suction or bronchoscope. A bronchoscopeis a long, narrow, fiberoptic, lighted viewing tube inserted through thenose or mouth. The physician can view as shown, for example, in FIG. 8,in a non-intubated patient, the vocal cords, the trachea (80), bronchi(83) (large airways to the lungs), and bronchioles (81) (smallerbranches of the bronchi) in order to evaluate, diagnose and/or treatcertain areas including performance of biopsies for examination oftissue, if medically indicated. The physician or health care providermay also remove secretions or foreign bodies and provide specializedtreatments using such bronchoscopy procedures. In a patient with atracheostomy, the vocal cords are note generally seen during abronchoscopic evaluation.

In an embodiment, FIG. 1B includes multi-attachment port (C) (37) which,for example, acts as a suction/bronchoscopy port, and includes aremovable cap (12) with plug (16) attachable to the cap (12). The cap(12) with plug (16), is used to close the opening to themulti-attachment port C (37), when not in use or not connected to thesuction or bronchoscope. An additional plug (36) situated above thedistal end of the swivel adapter (7) for example, at the ventilator portattachment, as shown at multi-attachment port A (39), may be used toclose the opening (14) of the suction/bronchoscopy port (37) in theevent for example, that the cap (12) is removed from the outercylindrical surface of the suction/bronchoscopy port (37).

As described above, the disclosed speaking valve adapter (28) of FIG. 1Bis designed to include a speaking valve (15) that is orthogonal with anddirectly connects to the tracheostomy port (9) (similar to FIG. 1A)rather than the device of FIG. 6, in which the speaking valve (60) isarranged directly in-line and connects to the ventilator port (61), asshown in FIG. 6. The design of the disclosed embodiment is associatedwith improved results for both speaking ability and speech therapyduring respiratory therapy. The disclosed embodiment is also associatedwith an improved weaning process for patients connected to newerventilator technologies. These ventilators are also more finelycalibrated and are more tailored to a patient's unique needs. Forexample, certain of the ventilator technologies implement sensors thatare neural-based. These sensors and ventilators work with a specializednasal/oral gastric tube, while also sensing the electrical pulses sentfrom the brain to the diaphragm (82) as shown in FIG. 8. These sensorsallow the ventilator to deliver pressure proportional to the amount ofdiaphragmatic activity they measure. These newer ventilator technologiesmay use diaphragmatic electromyography to trigger ventilation in a morenatural manner.

In oxygenation, newer low and high flow continuous 0-2 delivery systemscan be used via the side (for example, port C (37)) while still beingable to utilize suction ability as well as a speech enabling valveadapter (28). Additional oxygenation resources such as CPAP systems canbe applied via the ventilator at multi-attachment Port A (39). Duringoxygenation therapies, low and high flow continuous oxygen (O₂) deliverysystems are implemented as well as continuous positive airway pressuredelivery systems.

Lung recruitment therapy is a newer concept, which involves ventilationand hyperinflation techniques. This can be accomplished by mechanicalventilation systems. In another disclosed embodiment, manualresuscitation bag valve devices can be applied. Newer Bi-Level PositiveAirway Pressure ventilation systems may also be applied, as well as aPositive Expiratory Pressure generating delivery system. Othercontemplated uses include ventilation and hyperinflation (lungrecruitment therapy) implementations. Mechanical ventilation system,manual resuscitation valve device systems, bi-level position airwaypressure ventilation system and positive expiratory pressure generatingdelivery systems, are further contemplated implementations that are usedwith the speaker valve adapter (28).

Gas monitoring systems may also be implemented in certain embodiments ofthe speaking valve adapter (28), including oxygen and carbon dioxide,but also nitric oxide and anesthesia. Exhaled carbon dioxide monitoringdevices as well as nitric oxide gaseous sample monitoring devices can beimplemented. Additional ports (for example, one or more ofmulti-attachment Port A (39), multi-attachment Port B (38) and/ormulti-attachment Port C (37) of adapter (28) in FIG. 1B) provide theability to monitor both inhaled and exhaled oxygen. Uniquely, anesthesiagaseous delivery system monitoring devices may be implemented as wellvia multi-attachment Port B (38) during inspired or expired gas flow. Inother embodiments or aspects, an anesthesia machine is similar to aventilator and is attached via multi-attachment Port A (39). Since thepatient would be unconscious and the anesthesia ventilator machineventilating, a speaking valve would not be utilized in such embodiment.In fact, the entire assembly might be removed and not used at all,although valuable suctioning ability would be lost temporarily.

In other embodiments or aspects, during gas monitoring purposes, devicessuch as exhaled carbon dioxide gaseous sample monitoring devices, nitricoxide gaseous sample monitoring devices, inhaled/exhaled oxygen gaseoussample monitoring devices or anesthesia gaseous delivery systemmonitoring devices, may be implemented with the speaking valve adapter(28) and attached at multi-attachment Port C (37) of adapter (28), asshown in FIG. 1B.

In another embodiment or aspect, additional diagnostic purposes includeutilizing a Wrights Respirometer spirometry flow measurement device. Inaddition, a negative inspiratory force can be measured using a negativeinspiratory force measurement device that is couplable to the adapter(28) at one of Port A (39), Port B (38) and/or Port C (37) in FIG. 1B.

By virtue of its adaptable medical design, in other embodiments oraspects, the adapter (28) also permits bronchoscopies to be performed.Sputum induction techniques and the ability to capture specimens arealso enhanced by the implementation of the adapter design of FIG. 1B, bycoupling applicable devices for such procedures to adapter (28) at oneof multi-attachment ports, Port A (39), Port B (38) and/or Port C (37)shown in FIG. 1B.

Some of the recited benefits of secretion management includesmobilization and removal requirements. The adapter of FIG. 1B will allowfor sound wave (ultrasonic hyper-resonant/flow force generated) devicesto be implemented in certain embodiments. An In-Exsufflator (CoughAssist) positive and negative secretion mobilization device can also beutilized with the adapter (28) of FIG. 1B with ease and lack ofinterruption of ventilation. Finally, in other embodiments or aspects,invasive closed and open suction catheter secretion removal systemsanalogous to bronchoscopies, can further be implemented and attached tomulti-attachment Port C (37) of adapter (28) in FIG. 1B.

In other embodiments or aspects, the adapter (28) facilitatesadministration of medication that enables respiratory treatment.Standard mainline nebulizer devices may be administered to patients asindicated during respiratory therapy, but in addition, side streamnebulization devices may be implemented using the adapter (28) of FIG.1B, by coupling such nebulizer devices to multi-attachment Port B (38)and/or multi-attachment Port C (37). In yet other embodiments oraspects, metered dose inhalers can also be implemented using one of theports (for example, multi-attachment Port A (39), Port B (38) and/orPort C (37)) of adapter (28).

The speaking valve (28) thus can be implemented while simultaneouslyallowing for ventilation and medical management as provided in theforegoing. The Passy-Muir® valve is one of the more common of suchspeaking valve devices previously used. However, without the recitedbenefits of the disclosed speaking valve, other one-way adapter devicesmay be implemented as well in other contemplated embodiments.

In other embodiments or aspects, combination oxygenation, ventilation,secretion removal and medication delivery purpose devices such asMetaNeb© delivery system are couplable with, for example,multi-attachment Port A (39), Port B (38) and/or Port C (37) of adapter(28) shown in FIG. 1B.

FIG. 2 is an illustration of another contemplated embodiment of thespeaking valve adapter including an opening (22) for connection of thetracheostomy/endotracheal port (27) to either a tracheostomy tube (44)or an endotracheal tube (70). The suction/bronchoscopy port (21)connects optionally with removable cap (26) to a suction and/orbronchoscopy attachment. The ventilator interface port (23) includes twocylindrical tubes that are disposed in a skewed fashion and supportone-directional air-flow associated with either the expiration of air(25) from the human's lungs and/or the inhalation of air (24) into thehuman's lungs.

FIG. 3 is an illustration of an embodiment of the adapter (34) with anopening (32) for supporting connection or attachment of thetracheostomy/endotracheal port (34) to either a tracheostomy tube (44)or an endotracheal tube (70). The ventilator port (33) supportingattachment to the ventilator, is orthogonal relative to the speakingvalve (31).

It is noted that with each of the shown embodiments of the invention,the ventilator may ventilate the patient whether the tracheostomy cuffis inflated or not. As with any speaking valve, the effect on theexpiratory phase while speech actually occurs is noted by the backpressure being presented by the ventilator to the air column in thetracheostomy during the expiratory cycle, and further, the speakingvalve critically deflecting or re-directing air back up the vocal cords.This feature could also be accomplished with known “in line” speakingvalves as shown in FIG. 6. However, the cuff (41) on the patient must bemandatorily deflated or otherwise, would result in serious complicationsto the patient. If the cuff (41) had to be re-inflated due to, forexample, progressive hypercapnia (hypoventilation) or emergent changesin the patient's status, the speaking valve of FIG. 6 would have to beremoved and the ventilator reset which is a significant drawback in theuse of these “in-line” speaking valves.

In other embodiments or aspects, during implementation of the disclosedspeaking valve adapter shown in either FIG. 1A, 2 or 3, the patient'scuff (41) may be inflated without changing the speaking functionalityand without disruption of the connection to the ventilator. Since thespeaking valve is orthogonal relative to the tracheostomy port (9),(shown in FIGS. 1A and 2) and orthogonal relative to the ventilator port(33) (as shown for example, in FIG. 3), any functionality is therebypreserved while even making rapid ventilator adjustments to suit thepatient's current breathing requirements and vital signs. An additionaladvantage of the disclosed embodiments is that the speaking valveadapter allows for further refined calibration of continuous ventilatorsupport in both the inspiratory and expiratory phases of respiration,which is critical for the weaning process. When applying variousfeatures of newer ventilation features, it is noted that known speakingvalves have been opened during inspiration phase despite any appliedpositive pressure ventilation. Therefore, a patient during inhalationwould or could derive part of an inhaled breath from the outsideatmosphere separate from the ventilator while also being supplied withadditional pressure support from the ventilator. During expiration, itwas found that the known valves closed and the ventilator was also ableto register an end expiratory pressure level.

During the weaning process, air can be inhaled from non-ventilatorproduced air pressure and a fractional amount of air may travel inthrough the speaking valve. This amount of air can be gauged by theamount of work expended by the ventilator or (based on the alreadydescribed indicators available in newer ventilator technologies) ascompared to the patient breathing levels.

It is also noted that newer ventilator technologies also incorporatecarbon dioxide sensors which can determine exhaled carbon dioxide levelsby allowing back pressure air to be measured during the expiratory phaseof respiration. During the expiratory phase, the speaking valve isclosed and back pressure in the ventilator deflects air back up into thetracheostomy (with the cuff being deflated) and is expelled through thevocal cords of the patient. An ideal amount of PEEP/EPAP can also beoptimized for prevention of atelectasis (collapse of the lung tissueand/or lung). This additional control, in effect enhances the use of thespeaking valve (15), (20) or (30) by further manipulating the expiratoryphase of the patient's breathing.

Another advantage of using the adapter in accordance with one of thedisclosed embodiments, is the improved synchrony between the ventilatorsand the patient as soon as neural inspiration commences. The level ofsupport and assistance that will be provided to the patient duringinspiration is now determinable by the patient's own respiratory demandsas now measurable using the newer ventilator technologies. This is alsotrue for the cycling-off phase whereby the ventilator cycles offinspiration once alerted to the onset of neural expiration. Signalsimplemented in newer ventilator technologies are able to sustainsynchrony between the patient and the ventilator. An incidental benefitof improved synchrony between patient and ventilator is improved abilityto speak while connected to the ventilator. Another incidental benefitis protection of the patient's lungs and overall recovery process sincethe newer ventilators prevent over or under assistance of the patientwhich could otherwise, significantly hinder the patient's recoveryprocess. For example, over assistance can prevent restoration offunctioning and strength of diaphragm muscle(s).

Generally, the respiratory muscles and the ventilator will be driven bythe same signals which essentially match the patient's neural demands.The newer ventilator technologies measure the electrical activity of thediaphragm using known methods such as insertion of an Edi catheter. Anexample Edi catheter (90) is shown in FIG. 9. The Edi catheter (90)includes at least a feeding lumen connector type with universal funnelconnector and an auxiliary lumen connect with reducer and plug. The Edicatheter (90) detects electrical activity of the diaphragm and includesa barium strip for x-ray identification. They are available in differentproportions for a full range of patients including neonates, pediatricsand adults. The catheter (90) also works as a normal naso gastricfeeding tube. Such signals can be used to assess respiratory drive,volume requirements, and the effects of ventilator settings on theparticular patient. An esophageal ECG (electrocardiogram) can also beimplemented during ventilator management to measure, among otherfactors, decreases or increases in pressure as well as respiratoryrates.

The result of such additional neurally-based detection and otherventilator management measures minimizes patient discomfort andagitation, promoting spontaneous breathing and in effect, reducingsedation when stable breathing conditions are met by and for thepatient. As described, the current ventilators generally provideadditional information for ventilator management and respiratory caresuch as respiratory drive, volume requirements, greater effect oftailored ventilator settings and greater indicators for sedation andweaning. Health care providers can now take advantage of these addedfeatures while implementing the speaking valve in accordance with thedisclosed embodiments. Improved results include the patient's ability tospeak sooner and more comfortably while attached to the ventilatorsincluding effectively improving the overall weaning process.

FIG. 10 is an example ECG and Edi signal reading output including PEEP,oxygen, and additional output levels. The Edi signal reading havingcertain amplitude values measured in μV is shown at signal output (100)with resultant Edi peak and min values shown at (101). These signalreadings are all implemented in newer ventilator technologies to assistwith adapting the patient to his or her optimal breathing levels whilepermitting weaning and speech recovery efforts. In ventilatorsimplementing neuro-ventilatory coupling, the technology is based on theprinciple that the phrenic nerve is known to cause diaphragm excitationand stimulates many of the muscles of the upper thoracic cage includingthe diaphragm. The neural control of respiration originates in therespiratory center and these signals are transmitted through the phrenicnerve to excite the diaphragm. Therefore, these neural-based ventilatorsare controlled directly by the patient's own neural control ofbreathing.

Certain levels are able to be observed such as diaphragm excitation,diaphragm contraction, chest wall and lung expansion, airway pressure,flow and volume. The newer ventilators implement certain patientcontrols using neural triggers (including initiation of breath,inspiratory time, rate, peak pressure and termination of breath). Thesesignals are monitored using bipolar electrodes, for example, usingelectrodes mounted in the Edi catheter (90). Various ranges of modelsand sizes of these catheters are available which ensures optimizedsignal quality across all patient categories and conditions. It isfurther indicated for the insertion of the Edi catheters, that they arepositioned properly and to a measured depth in the patient cavity whichan esophageal ECG can confirm. A prominent P-wave is generally visiblein the uppermost channel with a decline of P-wave amplitudes in thelower leads, once the catheter is properly positioned.

These neural-ventilator controls can include FiO2, PEEP, otherventilator specific levels such as a neurally adjusted ventilator assistlevel, Apnea time (minimum rate) and peak inspiratory pressure alarm.Synchrony is achieved observing factors such as initiation of breath,size of breath and termination of breath. These ventilators set valuessuch as a neurally-adjusted ventilator assist level by converting, forexample, the Edi signal into a pressure level. The higher the neurallyadjusted ventilator assist level, the ventilator must perform additionalwork. The goal of unloading the work of breathing from the patient tothe ventilator without over assisting the patient is more successfulwith these neural-based ventilators. In parallel is the greater level ofsuccess with speech therapy efforts and the mere ability to speak usingthe speaking valve of FIG. 1A, 2, or 3, while connected to suchventilators.

Non-invasive electrical impedance tomographic (EIT) monitors may also beimplemented with the speaking valve adapter of FIG. 1A, 2 or 3, andventilators, in order to monitor and determine ventilation reactedimpedance changes that occur in a thoracic cross-section. Such monitorsenable the assessment of regional ventilation distribution as well asshort-term changes in end-expiratory lung volumes. These monitors helpassess conditions associated with ventilator use such as atelectasis(lung failure), over-inflation, air trapping, pleural effusion (excessfluid between the two membranes that cover the lungs) or pneumothorax (abuildup of air in the space between the lung and the chest wall, i.e.,pleural space). This information may be displayed as images, waveformsor parameters to trend display of changes in end-expiratory lung volume.

Managed ventilator and speech recovery is enhanced when implementingsystems using neural-ventilator type models coupled with the speakingvalve adapter of the disclosed technology to assist the patient withweaning and speech during respiratory recovery and may include the useof additional monitors such as, for example, EIT type monitors, foreffective ventilator management.

In other embodiments or aspects, FIG. 11 shows example ventilatorsettings that are set to optimize the implementation of theabove-described speaking valve adapter, in accordance with the disclosedrespiratory management system. The ventilator settings could be usedwith a tracheostomy with the balloon cuff also being deflated. In anormal ventilator mode, when the balloon is inadvertently deflated,experiencing leaks or is otherwise ruptured, the ventilator does notsense any return volume. Consequently, the ventilator will constantlyalarm and will auto-cycle ventilate the patient over 40-50 times. Thesettings displayed include N A/C of 8.0 (110) NIV (non-invasiveventilation) with a V-TRIG (111) of 6. With these type of settings forthe ventilator, an alarm cycling condition is overcome. In the top bar,it is noted that V_(TE) (112) is 0 and V_(ETOT) (113) is 0.01, butreflect the timing of the respiratory cycle at the moment shown in FIG.11. In such case, no air is coming or being diverted back, but rather isdirected through the vocal cords by the speaking valve, which permitsspeech of the patient, while connected thereto, during such respiratorycycle(s).

NIV refers to non-invasive ventilation which is a newer advancedfunction of the newer generation of ventilators. The wave form (114)demonstrates the ability of the ventilator to keep the lungs inflateddespite the open circuit and the balloon being deflated. This in effect,creates a pattern that is similar to airway pressure releaseventilation, i.e. APRV. The lung deflates and then rapidly inflatesagain rather than inflates, deflates and pauses in a near empty FVC(forced vital capacity) at FRC (functional residual capacity) ratherthan full inflation at near TLC (Total Lung Capacity) with attention toavoiding over-inflation as is seen here utilizing the settings as shownin FIG. 11. While these settings are inherent with all of the newerventilators, they are not present in older generation models.

Prior art utilizing speaking valves have placed them in line with theventilator circuit. The intent with most speaking valves is to placethem on the tracheostomy. Placing them by the in-line arrangement hasmultiple hazards, which are overcome with the current disclosedembodiments. Using a speaking valve orthogonal to the ventilator with acuff, ongoing ventilation remains possible with suctioning possible asneeded but, in effect, improving the overall ability for the patient toproduce speech in a safe and more effective manner. When the patientmakes an effort, not displayed here, but seen on manikin testing, thespeaking valve still has air ingressing during inspiration despiteventilator support. Thus, it is a patient determined function balancedagainst ventilator support that determines just how much outside airversus ventilator support is being used by the patient. As lessventilator support is used, more outside ambient air is used as the lungheals. This healing process cannot be predicted or forced. The healingprocess is also dictated by the healing of an organ at whatever pace isforeordained by the original nature of the pulmonary injury and/or therespiratory condition.

Although preferred embodiments of the present invention have beendescribed herein with reference to the accompanying drawings, it is tobe understood that the invention is not limited to those preciseembodiments and that various other changes and modifications may beaffected herein by one skilled in the art without departing from thescope or spirit of the invention, and that it is intended to claim allsuch changes and modifications that fall within the scope of theinvention.

The illustrations of embodiments described herein are intended toprovide a general understanding of the structure of various embodiments,and they are not intended to serve as a complete description of all theelements and features of the speaking valve adapter and respiratorymanagement systems imploring ventilators and the disclosed adapter, thatmight make use of the structures described herein. Many otherembodiments will be apparent to those of skill in the art upon reviewingthe above description. Other embodiments may be utilized and derivedtherefrom, such that structural and logical substitutions and changesmay be made without departing from the scope of this disclosure. Figuresare also merely representational and may not be drawn to scale. Certainproportions thereof may be exaggerated, while others may be minimized.Accordingly, the specification and drawings are to be regarded in anillustrative rather than a restrictive sense.

Such embodiments of the inventive subject matter may be referred toherein, individually and/or collectively, by the term “embodiment”merely for convenience and without intending to voluntarily limit thescope of this application to any single embodiment or inventive conceptif more than one is in fact disclosed. Thus, although specificembodiments have been illustrated and described herein, it should beappreciated that any arrangement calculated to achieve the same purposemay be substituted for the specific embodiments shown. This disclosureis intended to cover any and all adaptations or variations of variousembodiments. Combinations of the above embodiments, and otherembodiments not specifically described herein, will be apparent to thoseof skill in the art upon reviewing the above description.

The Abstract is provided to comply with 31 C.F.R. § 1.72 (b), whichrequires an abstract that will allow the reader to quickly ascertain thenature of the technical disclosure. The Abstract generally permits oneto determine quickly from a cursory inspection of thereof, the natureand gist of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims. In addition, in the foregoing DetailedDescription, it can be seen that various features are grouped togetherin a single embodiment for the purpose of streamlining the disclosure.This method of disclosure is not to be interpreted as reflecting anintention that the claimed embodiments require more features than areexpressly recited in each claim. Rather, as the following claimsreflect, inventive subject matter lies in less than all features of asingle disclosed embodiment. Thus, the following claims are herebyincorporated into the Detailed Description, with each claim standing onits own as a separately claimed subject matter.

Although specific example embodiments have been described, it will beevident that various modifications and changes may be made to theseembodiments without departing from the broader scope of the inventivesubject matter described herein. Accordingly, the specification anddrawings are to be regarded in an illustrative rather than a restrictivesense. The accompanying drawings that form a part hereof, show by way ofillustration, and not of limitation, specific embodiments in which thesubject matter may be practiced. The embodiments illustrated aredescribed in sufficient detail to enable those skilled in the art topractice the teachings disclosed herein. Other embodiments may beutilized and derived therefrom, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. This Detailed Description, therefore, is not to betaken in a limiting sense, and the scope of various embodiments isdefined only by the appended claims, along with the full range ofequivalents to which such claims are entitled.

In the foregoing description of the embodiments, various features aregrouped together in a single embodiment for the purpose of streamliningthe disclosure. This method of disclosure is not to be interpreted asreflecting that the claimed embodiments have more features than areexpressly recited in each claim. Rather, as the following claimsreflect, inventive subject matter lies in less than all features of asingle disclosed embodiment. Thus the following claims are herebyincorporated into the Detailed Description, with each claim standing onits own as a separate example embodiment.

The invention claimed is:
 1. A speaking valve adapter for assisting withspeech or language expression during respiratory recovery of a patientwhich enables natural vocal cord sounds produced on exhalation, thespeaking valve adapter including: a speaking valve port, the speakingvalve port being orthogonal to a first interface port and a secondinterface port, the speaking valve port configured to be connected to aspeaking valve, the speaking valve port further configured to be used asa first multi-attachment port associated with respiratory therapy forsimultaneous attachment of devices or medical tubing and devices; thefirst interface port adapted to be couplable to tracheostomy tubing thatcomprises a cuffed arrangement including an inflatable portion locatedalong a portion of the tracheostomy tubing, which enables balancing ofatmospheric air with ventilator air during inspiration, the inflatableportion of the cuffed arrangement configured for deflation orre-inflation during respiratory therapy, the natural vocal cord soundsbeing produced when back pressure is presented by ventilator air to anair column in the tracheostomy tubing during an expiratory cycle of aventilator when the inflatable portion is deflated; the second interfaceport configurable to be used as a second multi-attachment portassociated with respiratory therapy for simultaneous attachment ofdevices or medical tubing and devices; and a third interface portadapted to be directly coupled to the ventilator, the speaking valveadapter enabling production of the natural vocal cord sounds onexhalation when air passes through vocal cords as guided by the speakingvalve adapter, with back pressure being presented by the ventilator tothe air column in the tracheostomy tubing and the speaking valve portduring the expiratory cycle, the speaking valve adapter therebydeflecting or re-directing air through vocal cords, while simultaneouslykeeping a functional residual capacity that avoids over-inflation andmaintains speaking functionality during ventilator support.
 2. Thespeaking valve adapter of claim 1, wherein the speaking valve adapter isused by the patient for producing at least one of sounds and words whileconnected to the ventilator.
 3. The speaking valve adapter of claim 2,wherein a positive end expiratory pressure level is set on theventilator while diverting air through the vocal cords during speech,thereby minimizing respiratory complications during speech.
 4. Thespeaking valve adapter of claim 1, wherein the first interface portfurther includes a swivel adapter surrounding an opening channel to thefirst interface port, and wherein the swivel adapter is configured topivot or rotate about the opening channel to the first interface portthereby permitting greater flexibility and increasing range of movementof the patient, while connected to the ventilator.
 5. The speaking valveadapter of claim 4, wherein the swivel adapter is further configured topermit greater flexibility between the tracheostomy tubing and thepatient, while connected to the ventilator.
 6. The speaking valveadapter of claim 1, wherein the third interface port is furtherconfigured to include a swivel adapter surrounding a channel to thethird interface port, and wherein the swivel adapter is configured topivot or rotate about the channel to the third interface port therebypermitting greater flexibility and increasing the range of movement ofthe patient, while connected to the ventilator.
 7. The speaking valveadapter of claim 1, wherein the second interface port further comprisesa plug for connection to an opening of the second interface port,thereby closing the opening to the second interface port.
 8. Thespeaking valve adapter of claim 1, wherein the third interface portfurther comprises a plug for connection to an opening of the thirdinterface port, thereby closing an opening to the third interface port.9. The speaking valve adapter of claim 1, wherein the speaking valveport further comprises a plug for connection to an opening of thespeaking valve port, thereby closing the opening.
 10. The speaking valveadapter of claim 1, wherein inspiration includes simultaneousinspiration from outside atmospheric air at sea level pressure andpressure support from the ventilator.
 11. The speaking valve adapter ofclaim 1, wherein at least one ventilator parameter is configured toreduce overall duration of ventilation and organ failure associated withconnection to the ventilator.
 12. The speaking valve adapter of claim11, wherein configuring the at least one ventilator parameter furthercomprises optimizing ventilator management of the patient, therebyreducing the overall duration of ventilation and organ failureassociated with connection to the ventilator.
 13. The speaking valveadapter of claim 1, wherein the first multi-attachment port is adaptedto be couplable to at least one of: a ventilator device, an expap/hyperinflation positive pressure manifolds system, a resuscitationdevice, a negative inspiratory force manometer, a respirometerspirometer device, a nebulizer device, a positive end expiratorypressure regulator, a speaking valve, an incentive spirometer, a coughassist device, and an end tidal capnography monitoring device.
 14. Thespeaking valve adapter of claim 1, wherein the second multi-attachmentport is adapted to be couplable to at least one of: a ventilator device,an ex pap/hyperinflation positive pressure manifolds system, aresuscitation device, a negative inspiratory force manometer, arespirometer spirometer device, a nebulizer device, a positive endexpiratory pressure regulator, an incentive spirometer, a cough assistdevice, and an end tidal capnography monitoring device.
 15. The speakingvalve adapter of claim 1, wherein the first interface port is adapted tobe couplable to tracheostomy tubing that is operable in a deflated cuffarrangement and enables balancing of atmospheric air with ventilatorair.
 16. A respiratory management system for assisting with speech orlanguage expression during respiratory recovery of a patient whichenables natural vocal cord sounds produced on exhalation, the systemincluding: a ventilator having settings configured to permit lungs ofthe patient to deflate and rapidly inflate continuously to maintain thelungs nearly inflated; a speaking valve adapter, the adapter beingconfigured to include: a speaking valve port, the speaking valve portbeing orthogonal to a first interface port and a second interface port,the speaking valve port configured to be connected to a speaking valve,the speaking valve port further configured to be used as a firstmulti-attachment port associated with respiratory therapy forsimultaneous attachment of devices or medical tubing and devices; thefirst interface port adapted to be couplable to tracheostomy tubing thatcomprises a cuffed arrangement including an inflatable portion locatedalong a portion of the tracheostomy tubing, which enables balancing ofatmospheric air with ventilator air, the inflatable portion of thecuffed arrangement configured for deflation or re-inflation duringrespiratory therapy, the natural vocal cord sounds being produced whenback pressure is presented by ventilator air to an air column in thetracheostomy tubing during an expiratory cycle of the ventilator whenthe inflatable portion is deflated; the second interface portconfigurable to be used as a second multi-attachment port associatedwith respiratory therapy for simultaneous attachment of devices ormedical tubing and devices; and a third interface port adapted to bedirectly coupled to the ventilator, the speaking valve adapter enablingproduction of the natural vocal cord sounds on exhalation when airpasses through the vocal cords as guided by the speaking valve adapter,with back pressure being presented by the ventilator to the air columnin the tracheostomy tubing and the speaking valve port during theexpiratory cycle, the speaking valve adapter thereby deflecting orre-directing air through vocal cords, while simultaneously keeping afunctional residual capacity that avoids over-inflation and maintainsspeaking functionality during ventilator support.
 17. The respiratorymanagement system of claim 16, wherein the speaking valve adapter isused by the patient for producing at least one of sounds and words whilethe patient is connected to the ventilator.
 18. The respiratorymanagement system of claim 16, wherein the first interface port furtherincludes a swivel adapter surrounding an opening channel to the firstinterface port.
 19. The respiratory management system of claim 16,wherein the ventilator further includes ventilator settings configurableto assist the patient with speech expression during respiratory recoveryof the patient.
 20. The respiratory management system of claim 19,wherein the ventilator settings include at least one of N A/C and V-TRIGparameters.